Barr’s Tamoxifen Approval Barred Until Resolution Of ANDA “Deficiencies”
Barr must resolve recently identified "deficiencies" in labeling for its tamoxifen ANDA before FDA will grant final approval of the Nolvadex generic, an Oct. 2 agency memo says
Barr must resolve recently identified "deficiencies" in labeling for its tamoxifen ANDA before FDA will grant final approval of the Nolvadex generic, an Oct. 2 agency memo says